Further study details as provided by Sociedad Andaluza de Enfermedades Infecciosas:

Primary Outcome Measures:

Development of Tuberculosis

Suspension of chemoprophylaxis due to adverse effects

Secondary Outcome Measures:

Suspension of chemoprophylaxis due tovoluntary withdrawal

Mortality.

Estimated Enrollment:

300

Study Start Date:

January 1994

Estimated Study Completion Date:

December 1998

Detailed Description:

DESINGS: We performed a randomised, comparative and open clinical assay carried out in 316 HIV-infected patients. The patients were randomly assigned to one of three regimens, 108 to isoniazid for six months (6H), 103 to rifampin and isoniazid for three months (3RH), and 105 to pyrazinamide and rifampin for two months (2RZ).

RESULTS: The TB rates (cases per 100 persons/year) in the three treatment groups were 3.4 in 6H, 4.5 in 3RH and 1.9 in 2RZ. The relative risk for TB with 6H as compared with 2RZ was 1.76, and with 3RH, 2.34. Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects. Seven patients were withdraw due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ). No appreciable differences were found among the three regimens.

CONCLUSION: In our study the 2RZ regimen was as safe as the 6H and 3RH regimens. We have nor observed a higher incidence of hepatotoxicity in patients who received 2RZ.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV infection confirmed by ELISA and Western blot

Age between 18 and 65 years

Life expectancy greater than two years

Reactivity to PPD > 5 mm

Exclusion Criteria:

Presence of active tuberculosis

Background of previous antituberculosis therapy or chemoprophylaxis

Presence of symptoms or signs suggesting pulmonary or extra-pulmonary tuberculosis

History of hypersensitivity to the drugs used in the study (isoniazid, rifampin or pyrazinamide)

Aspartate-aminotransferase and/or alanine-aminotransferase plasma concentrations more than or equal to four times their normal values, total bilirubin more than 2 mg/ml, and/or creatinine more than 2 mg/ml

Pregnancy

Undergoing treatment incompatible with any of the drugs used in the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402454